ABSTRACT

INTRODUCTION

The information provided by pharmaceutical sales representatives has been shown to influence prescribing. To enable safe prescribing, medicines information must include harm as well as benefits. Regulation supports this aim, but relative effectiveness of different approaches is not known. The United States (US) and France directly regulate drug promotion; Canada relies on industry self-regulation. France has the strictest information standards.

METHODS

This is a prospective cohort study in Montreal, Vancouver, Sacramento and Toulouse. We recruited random samples of primary care physicians from May 2009 to June 2010 to report on consecutive sales visits. The primary outcome measure was “minimally adequate safety information” (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications).

RESULTS

Two hundred and fifty-five physicians reported on 1,692 drug-specific promotions. “Minimally adequate safety information” did not differ: 1.7 % of promotions; range 0.9–3.0 % per site. Sales representatives provided some vs. no information on harm more often in Toulouse than in Montreal and Vancouver: 61 % vs. 34 %, OR = 4.0; 95 % CI 2.8–5.6, or Sacramento (39 %), OR = 2.4; 95 % CI 1.7–3.6. Serious adverse events were rarely mentioned (5–6 % of promotions in all four sites), although 45 % of promotions were for drugs with US Food and Drug Administration (FDA) “black box” warnings of serious risks. Nevertheless, physicians judged the quality of scientific information to be good or excellent in 901 (54 %) of promotions, and indicated readiness to prescribe 64 % of the time.

DISCUSSION

“Minimally adequate safety information” did not differ in the US and Canadian sites, despite regulatory differences. In Toulouse, consistent with stricter standards, more harm information was provided. However, in all sites, physicians were rarely informed about serious adverse events, raising questions about whether current approaches to regulation of sales representatives adequately protect patient health.

KEY WORDS

health policy patient safety primary care health services research

Electronic supplementary material

The online version of this article (doi:10.1007/s11606-013-2411-7) contains supplementary material, which is available to authorized users.

Notes

Author Contributions

BM had the primary responsibility for development of the study protocol and data collection tools, implemented the Vancouver study arm, oversaw data collection, wrote the plan for analysis, oversaw data cleaning, participated in data analysis, and drafted and revised the paper. She is the guarantor. JL was involved in protocol development and questionnaire design, plans for analysis, and drafting and revisions of the paper. JMS contributed to planning of data analysis, carried out statistical analysis, assisted in interpretation, and participated in drafting and revision of the manuscript. MD-B, MSW, GD and ER assisted in protocol development and instrument design, data interpretation and revisions of the manuscript; MD-B implemented the Montreal study arm; MSW the Sacramento study arm, and GD the Toulouse study arm. ER oversaw study administration in all four sites.

Barbara Mintzes had full access to all the data in the study and takes responsibility for the integrity of the data and accuracy of data analysis.

Acknowledgements: Contributors

We would like to thank the following people for their assistance with this study: Ken Bassett, Jim Wright, Alan Cassels, Aaron Tejani, Steve Morgan, Morris Barer, Florence Vandevelde, Line Guénette, Jean-Louis Montastruc, Les Toop, Dee Mangin, Libby Roughead, and Noordin Othman, for assistance with development of survey materials and study design; Theresa Lo, for her research on safety advisories; Chris Adlparvar for website development; Gisèle Foucault for translation; Aileen To and Jocelyne Gagne for administrative support; Lucy Lu, Kelp Watson, Amelia Daly, Neha Musini, Linda Lewis, Meghan Webb, Robert Renteria, Sara Pilote, Stacy Hayashi, Christine Dumolard, Marie Bounouh, Assia Meloua, Audrayanne Desjardins, and Jocelyne Bastien and Fabrice Amatulli, Union Régionale des Professionnels de Santé - Médecins Libéraux - Midi-Pyrénées, for assistance with recruitment of physicians; Anat Fisher, Herbert Fisher, Stephen Adams, Haithem Hamdi and Alexandra Laugerotte for coding of consistency with approved product information, and Pierre Biron for adjudication. Finally, we would like to extend our thanks to all of the physicians who participated in the study; without your help, this study would not have been possible.

Funders

This study was funded by the Institute of Health Services and Policy Research, Canadian Institutes of Health Research, and by Michael Smith Health Research Foundation. The funders had no involvement in the design or conduct of the study; in the collection, management, analysis, or interpretation of the data; or in preparation, review, or approval of the manuscript or decision to submit for publication.

Prior Presentation

Preliminary results of this study were presented in a poster at the 11th Annual International Society of Pharmacovigilance meeting in Istanbul, Turkey, in October 2011, and an oral presentation at the Canadian Cochrane Colloquium, Vancouver, B.C., February 2011.

Conflict of Interest

In 2010 Joel Lexchin was an expert witness for a law firm representing the family of a plaintiff who allegedly died from an adverse reaction from a product made by Allergan. He is currently on the Management Board of Healthy Skepticism Inc. Marie-Dominique Beaulieu is currently President of the College of Family Physicians of Canada (CFPC) (November 16 2012 to November 5 2013). She was not in this position when the study was conducted. None of the other authors have any conflicts of interest to declare.